MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE® II RT, RECON IB¿; NON-DEGRADABLE FIXATN FASTENER

Model Number	TIGHTROPE® II RT, RECON IB¿
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, it was reported by an arthrex employee via email that for an ar-1588rt-ib, tightrope® ii rt, reconstruction with internalbrace¿ ligament augmentation repair, while cinching graft into femoral tunnel, the tightrope snapped.This was detected during use in a graftlink procedure on (b)(6) 2025.The procedure was completed successfully as another tightrope was opened.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is confirmed by the attached picture, which shows that the suture was cut.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely cause of the reported failure can be attributed to user error, due to either excessive force used during suture passing or the device coming into contact with another device during use.

• Brand Name: TIGHTROPE® II RT, RECON IB¿
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22940376
• Report Number: 1220246-2025-03699
• Device Sequence Number: 9768663
• Product Code: MBI
• UDI-Device Identifier: 00888867291638
• UDI-Public: (01)00888867291638(11)241112(17)291031(10)15346788
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TIGHTROPE® II RT, RECON IB¿
• Device Catalogue Number: AR-1588RT-IB
• Device Lot Number: 15346788
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown